HIVNCT01203332
Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults
An observational study of HIV, run by University of North Carolina, Chapel Hill at 13 sites in 2 countries.
Trial summary
The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. Read more about this study
- Who is it for?
- Ages 13 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Effectiveness of different strategies in HIV testing and linkage to care
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,917 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jul 2010to Jan 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 24 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Adolescent and young adult Hispanic/Latino MSM and heterosexual men and women, aged 13-24 years, who meet all eligibility requirements for enrollment into the AVT or SSNIT component of the study.
- Inclusion Criteria
1a. Alternative Venue-Based Testing (AVT) Participants
- Self-identifies as being of Hispanic or Latino ethnicity;
- Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
- Self-reports a negative or unknown HIV status;
- Is male and self-reports any unprotected anal sex with a male sexual partner in the past three months; OR Is female and self-reports any unprotected anal or vaginal sex with two or more male sexual partners in the past three months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an injection drug user in the past 12 months;
- Willing to complete an HIV risk assessment;
- Willing to undergo HIV screening; and
- Able to understand and willing to provide signed informed consent/assent in English or Spanish. 1b. Social and Sexual Index Recruiter Participants
- Self-identifies as being of Hispanic or Latino ethnicity;
- Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
- Is male or female and self-reports being diagnosed with HIV in the past 12 months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an injection drug user in the past 12 months;
- Willing to complete a HIV risk assessment;
- Willing to undergo HIV screening (or an HIV confirmatory test if previously diagnosed);
- Willing to recruit one or more Latino/Latina family members, friends, or sexual partners who are between the ages of 13-24 years and who meet the criteria for a Social and Sexual Network Member for participation in the study; and
- Able to understand and willing to provide signed informed consent/assent in English or Spanish. 1c. Social and Sexual Network Members
- Self-identifies as being of Hispanic or Latino ethnicity;
- Provides verbal confirmation that his/her age is between 13 years, 0 days to 24 years, 364 days at the time of enrollment;
- Self-reports any anal or vaginal sexual activity in the past 3 months and any unprotected anal or vaginal sex in the last 12 months; OR Self-reports any history of injection drug use;
- Willing to complete a HIV risk assessment;
- Willing to undergo HIV screening; and
- Able to understand and willing to provide signed informed consent/assent in English or Spanish. 1d. Additional Inclusion Criteria for Social and Sexual Network Member Recruiters
- Is male or female and self-reports being diagnosed with HIV in the past 12 months; OR Is female and self-reports any unprotected anal or vaginal sex with a male sexual partner who was incarcerated in the past 12 months; OR Is male or female and self-reports any history of injection drug use; OR Is male or female and self-reports any unprotected anal or vaginal sex with an individual who is known to be HIV positive; OR Is male or female and self-reports any unprotected anal or vaginal sex with an IDU in the past 12 months; and
- Willing to recruit one or more Latino/Latina family members, friends, or sexual partners who are between the ages of 13-24 years and who meet the criteria for Social and Sexual Network Members for participation in the study.
- Exclusion Criteria 2a. All Participants
- Previous participation in ATN 096 as an AVT or a SSNIT study participant;
- Current or prior participation in ATN 084;
- Anything that would impair the participant's ability to provide informed consent/assent and/or interfere with the protocol's objectives; i.e., readily apparent psychiatric symptoms (hallucinations, thought disorder), visibly distraught (suicidal, homicidal, exhibiting violent behavior) or visibly intoxicated or under the influence of alcohol or other substances at the time of study enrollment, and
- Acute illness that, in the opinion of study staff, would interfere with the participant's ability to adhere to the protocol requirements and/or interfere with the protocol objectives. 2b. Additional Exclusion Criteria for Alternative Venue-Based Testing Participants
- Self-reports a prior diagnosis of HIV
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
University of Maryland
Baltimore, Maryland, 21201
Ruth M Rothstein CORE Center/ John H Stroger Jr Hospital
Chicago, Illinois, 60612
Childrens Diagnostic & Treatment Center
Fort Lauderdale, Florida, 33316
Childrens Hospital Los Angeles
Los Angeles, California, 90027
St. Jude Childrens Research Hospital
Memphis, Tennessee, 38105-2794
University of Miami School of Medicine
Miami, Florida, 33101
Mount Sinai Medical Center
New York, New York, 10128
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California San Francisco
San Francisco, California, 94117
University of South Florida
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10467
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
About this study
The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. In 10 of the 13 sites, comparisons will be made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying undiagnosed HIV in our target group of adolescents and young adults. All study participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening. Participants with presumptive HIV positive screening results will be referred to the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical care. Linkage to care for ATN 096 study participants will be conducted in accordance with the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as part of this protocol are linked with treatment and care.
- Conditions
- HIV
- Being tested
- Effectiveness of different strategies in HIV testing and linkage to care
- Keywords
- HIV testing, Latino, Latina, Men who have sex with men
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effectiveness of different strategies in HIV testing and linkage to careBehavioural
HIV testing Linkage to Care
| Study group | Role | What they receive |
|---|---|---|
| Alternative Venue Testing (AVT) | Participants recruited for testing through the AVT recruitment method. Receives: Behavioral: Effectiveness of different strategies in HIV testing and linkage to care | |
| SSNIT - Index Recruiter | Participants recruited for HIV testing and to bring members of their social and sexual network to the study. Receives: Behavioral: Effectiveness of different strategies in HIV testing and linkage to care | |
| SSNIT - Network Member | Participants recruited by someone in their social or sexual network to participate in the study, including HIV testing. Receives: Behavioral: Effectiveness of different strategies in HIV testing and linkage to care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of AVT strategy with SSNIT
To compare the relative effectiveness of AVT with SSNIT, which is a coupon-based index recruiter driven network recruitment strategy for identifying previously undiagnosed HIV infection among Hispanic/Latino adolescents and young adults aged 13-24 years.
Measured: 2 years
Facilitators & barriers to HIV testing
To examine factors that facilitate and/or hinder Hispanic/Latino adolescents and young adults in getting an HIV test (e.g., perceived risk for HIV, acculturation, homophobia, stigma associated with IDU).
Measured: 2 years
Sub-group differences
To explore the extent to which sub-group differences (e.g., origin of birth, age, level of acculturation) exist by prevalence of HIV-related risk behaviors, HIV testing, and mode of HIV transmission.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,917 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cherrie B. Boyer, Ph.D., Study chair, Adolescent Trials NetworkJonathan M. Ellen, M.D., Study chair, Adolescent Trials Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01203332
- Sponsor's protocol ID
- ATN 096
- Status last verified
- Mar 2016
- First submitted
- 15 Sep 2010
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Undiagnosed Asymptomatic HIV Infection in Hispanic/Latino Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT01203332
- Acronym / sponsor ID
- ATN 096
- Conditions
- HIV
- Keywords
- HIV testing, Latino, Latina, Men who have sex with men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,917 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), National Institute of Mental Health (NIMH)
- Study start
- Jul 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 16 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research will include adolescent and young adult Hispanic/Latino men who have sex with men (MSM) and heterosexual men and women, aged 13-24 years, and will be based at 13 ATN Adolescent Medicine Trial Units (AMTUs) that provide clinical care and psychosocial services to the target group. In 10 of the 13 sites, comparisons will be made between alternative venue-based testing (AVT) and social and sexual network-based interviewing and HIV testing (SSNIT) strategies to assess which, among these approaches, is the most effective means for identifying undiagnosed human immunodeficiency virus (HIV) in young, at-risk Hispanics/Latinos. Three of the sites will focus solely on use of SSNIT for identifying undiagnosed HIV in our target group of adolescents and young adults. All study participants will complete an audio computer-assisted self-interview (ACASI) and undergo HIV screening. Participants with presumptive HIV positive screening results will be referred to the local AMTU for confirmatory testing, post-test counseling and referrals for linkage to HIV medical care. Linkage to care for ATN 096 study participants will be conducted in accordance with the Strategic Multisite Initiative for the Identification, Linkage, and Engagement in Care of Youth with Undiagnosed HIV Infection (SMILE in CARING for YOUTH) Program (ATN 093), a collaboration of the CDC and NICHD/ATN, to ensure that youth who test positive for HIV as part of this protocol are linked with treatment and care.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alternative Venue Testing (AVT) | – | Behavioral: Effectiveness of different strategies in HIV testing and linkage to careParticipants recruited for testing through the AVT recruitment method. |
| SSNIT - Index Recruiter | – | Behavioral: Effectiveness of different strategies in HIV testing and linkage to careParticipants recruited for HIV testing and to bring members of their social and sexual network to the study. |
| SSNIT - Network Member | – | Behavioral: Effectiveness of different strategies in HIV testing and linkage to careParticipants recruited by someone in their social or sexual network to participate in the study, including HIV testing. |
Who may qualify
- Ages
- 13 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent and young adult Hispanic/Latino MSM and heterosexual men and women, aged 13-24 years, who meet all eligibility requirements for enrollment into the AVT or SSNIT component of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Effectiveness of different strategies in HIV testing and linkage to careHIV testing Linkage to Care | Behavioural | Alternative Venue Testing (AVT), SSNIT - Index Recruiter, SSNIT - Network Member |
Primary outcome
Effectiveness of AVT strategy with SSNIT
Time frame: 2 years
To compare the relative effectiveness of AVT with SSNIT, which is a coupon-based index recruiter driven network recruitment strategy for identifying previously undiagnosed HIV infection among Hispanic/Latino adolescents and young adults aged 13-24 years.
Facilitators & barriers to HIV testing
Time frame: 2 years
To examine factors that facilitate and/or hinder Hispanic/Latino adolescents and young adults in getting an HIV test (e.g., perceived risk for HIV, acculturation, homophobia, stigma associated with IDU).
Sub-group differences
Time frame: 2 years
To explore the extent to which sub-group differences (e.g., origin of birth, age, level of acculturation) exist by prevalence of HIV-related risk behaviors, HIV testing, and mode of HIV transmission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cherrie B. Boyer, Ph.D. study chair
Adolescent Trials Network
Jonathan M. Ellen, M.D. study chair
Adolescent Trials Network
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by University of North Carolina, Chapel Hill at 13 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of AVT strategy with SSNIT (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.